Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol

Overview

The investigators plan to develop a novel method of estimating 5-ASA levels in the rectum at a mucosal level using in vivo rectal dialysis technique towards the eventual goal of determining the optimal dosing of Asacol® that would provide therapeutic levels of 5-ASA in the left colon.

Full Title of Study: “Measurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on Asacol”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2014

Detailed Description

Asacol® is mesalazine in a pH-dependent tablet (Eudragit S) that remains intact until reaching the terminal ileum. The tablet dissolves at a pH 7 or greater, allowing mesalazine release in the terminal ileum and throughout the colon; hence, it would be anticipated that this form of 5-ASA will produce higher concentrations in the left colon in patients with active ulcerative colitis compared to other immediate release forms of 5-ASA. However, preliminary research using dynamic computer modeling and simulation predicted that patients with active ulcerative colitis (characterized by an increased stool frequency) treated with Asacol® and Lialda (another delayed release formulation) will achieve very low 5-ASA levels in the sigmoid colon and rectum. The model predicts that these 5-ASA preparations will be relatively ineffective in treating the left side of the colon in active ulcerative colitis.

Interventions

  • Procedure: Rectal dialysis
    • Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels
  • Drug: Rectal dialysis
    • Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels

Arms, Groups and Cohorts

  • Active Comparator: 1200 mg Asacol once daily for 1 week
    • Rectal dialysis will be done after 1 week on 1200 mg asacol
  • Active Comparator: 2400 mg Asacol once daily for 1 week
    • Rectal dialysis will be done after 1 week on 2400 mg asacol

Clinical Trial Outcome Measures

Primary Measures

  • Detection of 5-ASA
    • Time Frame: 2 weeks after starting Asacol
    • 5-ASA to be measured using rectal dialysis technique in-vivo

Secondary Measures

  • Change in Detected 5-ASA With Change in Ingested Asacol Dose
    • Time Frame: 5 weeks after starting study
    • Comparison of 2-week and 5-week 5-ASA as measured thorugh rectal dialysis

Participating in This Clinical Trial

Inclusion Criteria

  • Eligible subjects would be healthy males and females – 18-45 years of age (inclusive) – Within 20% of normal body weight at screening – Who are able to give written informed consent. Exclusion Criteria:

  • History of any chronic illness – Evidence of significant organic or psychiatric disease on a brief health questionnaire – A history or presence of any condition causing malabsorption or an effect on gastrointestinal motility – A history of any gastrointestinal surgery – A history of acute or chronic renal insufficiency – Pre existing liver disease – A history of severe allergic reaction to salicylates, aminosalicylates or any of the ingredients of Asacol® tablets or a history of multiple food/drug allergies or if they are pregnant or lactating. – Subjects will be required to refrain from any prescription or nonprescription drug or herbal products except their birth control medications for gastrointestinal disorders for 7 days prior to dosing and during the study, till its completion at the end of the fifth visit.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • NorthShore University HealthSystem
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eli D Ehrenpreis, MD, Principal Investigator, NorthShore University HealthSystem

References

Stobaugh DJ, Deepak P, Thorpe M, Hannon B, Ehrenpreis ED. Simulated comparison of topical and oral formulations of 5-aminosalicylate for the treatment of ulcerative colitis. Inflamm Bowel Dis. 2013 Feb;19(2):301-8. doi: 10.1002/ibd.23003.

Reissman P, Ehrenpreis ED, Cohen S, Nogueras JJ, Zaitman D, Wexner SD. Electrolyte profiles within the ileoanal pouch: measurement by an in vivo equilibrium dialysis technique. Dig Liver Dis. 2003 Apr;35(4):251-5. doi: 10.1016/s1590-8658(03)00062-8.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.